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Characterization of Emotional Processing of Information in Bipolar Disorder and Schizophrenic Patients (EMOBISCHI)

Primary Purpose

Schizophrenia, Bipolar Disorder

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
behavioral and fMRI
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring emotional processing, action

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

healthy volunteers

Inclusion criteria

  • Informed Consent signed
  • Medical examination conducted before research participation
  • Age, sex and level of education paired with bipolar and schizophrenic patients)
  • French Language and Culture
  • normal or corrected vision and hearing to normal
  • affiliate Obligation to social security

Exclusion criteria

  • Topic included in an ongoing experiment
  • contraindication to MRI (metal hardware or electronic incompatible with MRI examination, permanent glasses, braces, Claustrophobia, cardiac or neurological stimulator, Clip unsecured vascular nonmagnetic metal Eclat)
  • Important Hearing Disorders and vision
  • neurological pathologies or past or current neuropsychiatric
  • Family history of psychiatric disorders
  • Drug treatment may modulate brain activity: benzodiazepines, antidepressants, neuroleptics, etc.
  • Alcohol Ingestion
  • Pregnant women, women in labor, nursing mother
  • All other categories of protected persons

bipolar patients

Inclusion criteria

  • Informed Consent signed
  • Review medical and psychiatric assessment and inclusion made before participation in research
  • Membership or beneficiary of a social security scheme
  • Age over 18 years
  • Language and French culture
  • study BAC level or equivalent
  • normal or corrected vision and hearing to normal
  • Inpatient and outpatient
  • Diagnosis of bipolar disorder type I and II DSM-IV TR (A.P.A 1994)
  • Clinical Stability (inter-Critical) for at least three months with scores of ladders MADRS <15 and YMRS <12.
  • In case of anxiety symptoms, prescription Cyanemazine® or Hydroxyzine® be allowed, at low doses (<75 mg cyamemazine and hydroxyzyne).

Exclusion criteria

  • Patient Refusal
  • Diagnosis of bipolar disorder with rapid cycling and mixed episodes
  • psychiatric pathology addictive disorder or schizophrenia / schizoaffective
  • neurological pathologies or progressive neurosurgical
  • Personal history of seizures
  • Treatment with electroconvulsive therapy (ECT) in the 6 months preceding the assessment.
  • Patients hospitalized under stress or under legal protection measure (guardianship, curatorship)
  • Subject deprived of liberty by judicial or administrative decision
  • Contraindications to the practice of MRI equipment or incompatible metal or electronic foreign body with MRI examination, permanent glasses, braces, Claustrophobia, cardiac or neurological stimulator, Clip unsecured vascular nonmagnetic metal Eclat)
  • significant disorders of hearing and vision
  • Alcohol Ingestion
  • Pregnant women, women in labor, nursing mother

schizophrenic patients

Inclusion criteria

  • Informed Consent signed
  • Review medical and psychiatric assessment and inclusion made before participation in research
  • Membership or beneficiary of a social security scheme
  • Age over 18 years
  • Language and French culture
  • study BAC level or equivalent
  • normal or corrected vision and hearing to normal
  • Inpatient and outpatient
  • diagnosis of schizophrenic disorders such deficit, paranoid and undifferentiated
  • clinical stability for three months with PANSS scores <120 and no mood episode characterized (MADRS <15; YMRS <12)

Exclusion criteria

  • Patient Refusal
  • neurological pathologies or progressive neurosurgical
  • psychiatric pathology addictive
  • Patients hospitalized under stress or under legal protection measure (guardianship, curatorship)
  • Subject deprived of liberty by judicial or administrative decision
  • Contraindications to the practice of MRI equipment or incompatible metal or electronic foreign body with MRI examination, permanent glasses, braces, Claustrophobia, cardiac or neurological stimulator, Clip unsecured vascular nonmagnetic metal Eclat)
  • significant disorders of hearing and vision
  • Alcohol Ingestion
  • Pregnant women, women in labor, nursing mother

Sites / Locations

  • GrenobleUniversityHospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Bipolar

Schizophrenic

Control

Arm Description

bipolar patients type I or II (DSM-IV TR), euthymic phase

schizophrenic loss or paranoid or undifferentiated patients

control group (paired in age and sex for patients)

Outcomes

Primary Outcome Measures

Psychometric evaluation
PANSS - POSITIVE AND NEGATIVE SYNDROME SCALE Scale with 30 items
Psychometric evaluation
MADRS - Montgomery Asberg Depression Rating
Psychometric evaluation
YMRS - Young Mania Rating Scale
Self-Questionnaire
SHAPS - Snaith-Hamilton Pleasure Scale Starkstein STAI Y - State-Trait Anxiety Inventory AIM: "affect intensity measure" ALS: "affective lability scale" MATHYS
Cognitive questionnaire
CPT II - Conners' Continuous Performance Test II

Secondary Outcome Measures

Full Information

First Posted
June 16, 2016
Last Updated
October 10, 2018
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02841345
Brief Title
Characterization of Emotional Processing of Information in Bipolar Disorder and Schizophrenic Patients
Acronym
EMOBISCHI
Official Title
Characterization of Emotional Processing of Information in Bipolar Disorder and Schizophrenic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 29, 2020 (Anticipated)
Study Completion Date
February 29, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In the case of psychotic disorders such as bipolar disorder or schizophrenia, attention dysfunction contribute, according to the theories of neuroscience, the development of mood disorders following disturbances in the interaction-care emotion. In this context, the general objective of this research project is to refine our understanding of the similarities and distinctions between bipolar and schizophrenic patients in the basic emotional information processing. Specifically, these are: 1) to better understand what level of basic emotional information processing both conditions differ or are comparable and in what sense and 2) estimate, in both pathologies, the specific influence of the nature of the task of processing emotional information. To answer these questions, the investigators have developed a protocol to specifically target different information processing channels playing on the nature of the spatial frequency content of emotional natural scenes. To estimate in both pathologies, the specific influence of the nature of the task on emotional processing, 3 types of tasks are proposed: 1) a simple task perception and 2) -3) two tasks whose categorization one focused on the emotional feelings of the individual and the other on the tendency to action. Both tasks categorization should involve more specifically the ventromedial prefrontal cortex (CPFVM) and the dorsolateral prefrontal cortex (DLPFC) respectively. All patient data will be compared with data from healthy control participants.
Detailed Description
Main goals This research project generally aims to refine our understanding of the similarities and distinctions between bipolar and schizophrenic patients in emotional information processing. Specifically, these are: better understand what level of emotional information processing both conditions differ or are comparable and in what direction assess specifically in both pathologies, emotional regulation deficits through the realization of different cognitive tasks when processing emotional information. To answer these questions, the investigators developed an original protocol imaging functional magnetic resonance (fMRI) to specifically target different information processing channels playing on the nature of the spatial frequency content of emotional natural scenes (see Methods). emotional regulation deficits in both disorders will be addressed in part through here 3 types of tasks: 1) a simple task perception and 2) -3) two tasks categorization of which centered on the emotional feelings of the individual (task affective) and the tendency to action (motivational task). Both tasks categorization should involve more specifically the Prefrontal Cortex-Ventro Median (CPFVM) and Lateral Prefrontal Cortex-Dorso (DLPFC), respectively, distinguishing between the two categories of patients. All patient data will be compared to healthy control participants. This project will also allow us to improve our knowledge in bipolar and schizophrenic patients compared with control subjects, i) on the brain structures of networks involved in emotional information processing and emotional regulation, ii) functional relationships still unclear between neural structures involved in both processes and iii) the nature of the information passing through these networks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder
Keywords
emotional processing, action

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bipolar
Arm Type
Other
Arm Description
bipolar patients type I or II (DSM-IV TR), euthymic phase
Arm Title
Schizophrenic
Arm Type
Other
Arm Description
schizophrenic loss or paranoid or undifferentiated patients
Arm Title
Control
Arm Type
Other
Arm Description
control group (paired in age and sex for patients)
Intervention Type
Other
Intervention Name(s)
behavioral and fMRI
Intervention Description
The experience will include 3 sessions. Each session will consist of the presentation of a pseudo-random sequence of 24 black and white images of negative emotional natural scenes, 24 positive emotional situations and 24 neutral emotional situations. In the first session, participants will carry out an emotional assessment task: it will show at the end of each test his emotional feeling - pleasant, unpleasant or nothing - using a joystick. In a second session, the participant will perform a motor task decision: it will show at the end of each test the tendency to action he would handle the situation actually using 3 buttons également- approach withdrawal or neither one nor the other. In the third session, the participant will perform a simple visual perception task. To be comparable to the engine plane with the other sessions, a non-categorical motor task will be requested from participants.
Primary Outcome Measure Information:
Title
Psychometric evaluation
Description
PANSS - POSITIVE AND NEGATIVE SYNDROME SCALE Scale with 30 items
Time Frame
70 minutes
Title
Psychometric evaluation
Description
MADRS - Montgomery Asberg Depression Rating
Time Frame
15 minutes
Title
Psychometric evaluation
Description
YMRS - Young Mania Rating Scale
Time Frame
15 minutes
Title
Self-Questionnaire
Description
SHAPS - Snaith-Hamilton Pleasure Scale Starkstein STAI Y - State-Trait Anxiety Inventory AIM: "affect intensity measure" ALS: "affective lability scale" MATHYS
Time Frame
Few hours
Title
Cognitive questionnaire
Description
CPT II - Conners' Continuous Performance Test II
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
healthy volunteers Inclusion criteria Informed Consent signed Medical examination conducted before research participation Age, sex and level of education paired with bipolar and schizophrenic patients) French Language and Culture normal or corrected vision and hearing to normal affiliate Obligation to social security Exclusion criteria Topic included in an ongoing experiment contraindication to MRI (metal hardware or electronic incompatible with MRI examination, permanent glasses, braces, Claustrophobia, cardiac or neurological stimulator, Clip unsecured vascular nonmagnetic metal Eclat) Important Hearing Disorders and vision neurological pathologies or past or current neuropsychiatric Family history of psychiatric disorders Drug treatment may modulate brain activity: benzodiazepines, antidepressants, neuroleptics, etc. Alcohol Ingestion Pregnant women, women in labor, nursing mother All other categories of protected persons bipolar patients Inclusion criteria Informed Consent signed Review medical and psychiatric assessment and inclusion made before participation in research Membership or beneficiary of a social security scheme Age over 18 years Language and French culture study BAC level or equivalent normal or corrected vision and hearing to normal Inpatient and outpatient Diagnosis of bipolar disorder type I and II DSM-IV TR (A.P.A 1994) Clinical Stability (inter-Critical) for at least three months with scores of ladders MADRS <15 and YMRS <12. In case of anxiety symptoms, prescription Cyanemazine® or Hydroxyzine® be allowed, at low doses (<75 mg cyamemazine and hydroxyzyne). Exclusion criteria Patient Refusal Diagnosis of bipolar disorder with rapid cycling and mixed episodes psychiatric pathology addictive disorder or schizophrenia / schizoaffective neurological pathologies or progressive neurosurgical Personal history of seizures Treatment with electroconvulsive therapy (ECT) in the 6 months preceding the assessment. Patients hospitalized under stress or under legal protection measure (guardianship, curatorship) Subject deprived of liberty by judicial or administrative decision Contraindications to the practice of MRI equipment or incompatible metal or electronic foreign body with MRI examination, permanent glasses, braces, Claustrophobia, cardiac or neurological stimulator, Clip unsecured vascular nonmagnetic metal Eclat) significant disorders of hearing and vision Alcohol Ingestion Pregnant women, women in labor, nursing mother schizophrenic patients Inclusion criteria Informed Consent signed Review medical and psychiatric assessment and inclusion made before participation in research Membership or beneficiary of a social security scheme Age over 18 years Language and French culture study BAC level or equivalent normal or corrected vision and hearing to normal Inpatient and outpatient diagnosis of schizophrenic disorders such deficit, paranoid and undifferentiated clinical stability for three months with PANSS scores <120 and no mood episode characterized (MADRS <15; YMRS <12) Exclusion criteria Patient Refusal neurological pathologies or progressive neurosurgical psychiatric pathology addictive Patients hospitalized under stress or under legal protection measure (guardianship, curatorship) Subject deprived of liberty by judicial or administrative decision Contraindications to the practice of MRI equipment or incompatible metal or electronic foreign body with MRI examination, permanent glasses, braces, Claustrophobia, cardiac or neurological stimulator, Clip unsecured vascular nonmagnetic metal Eclat) significant disorders of hearing and vision Alcohol Ingestion Pregnant women, women in labor, nursing mother
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
VANESSA ESPIN
Phone
4 76 76 68 13
Ext
+33 (0)
Email
VEspin@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
EMILIE COUSIN, PhD
Phone
0 13 63 86 45
Email
cousin.emilie@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AURELIE CAMPAGNE, PhD
Organizational Affiliation
LPNC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
MIRCEA POLOSAN, PhD MD Pr.
Organizational Affiliation
GrenobleUniversityHospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
GrenobleUniversityHospital
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MIRCEA POLOSAN, PhD MD Pr.
Phone
4 76 76 53
Ext
+33 (0)
Email
mpolosan@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
AURELIE CAMPAGNE, PhD
Phone
4 56 52 85 08
Ext
+33 (0)
Email
aurelie.campagne@univ-grenoble-alpes.fr

12. IPD Sharing Statement

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Characterization of Emotional Processing of Information in Bipolar Disorder and Schizophrenic Patients

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